510(k) Report

FDA product code · General hospital

Injector, Pen

NSCClass II21 CFR 880.5860510(k) required1 decision since 20070 recalls

1 FDA decision since 2007. No recall names this code. The most-cited predicate is K063151, named by 1 later device.

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of NSC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NSC

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NSC

Too few NSC 510(k)s in any year since 2007 to give a median.

Recalls per year · NSC

No recall names NSC since 2007.

Adverse event reports per year · NSC

7in 2025

2008: 12009: 362010: 1052011: 912012: 462013: 222014: 342015: 552016: 382017: 92018: 162019: 902020: 342021: 222022: 92023: 152024: 272025: 7
2007high 105 (2010) · low 0 (2007)2025

MAUDE reports naming product code NSC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20090—036
20100—0105
20110—091
20120—046
20130—022
20140—034
20150—055
20160—038
20170—09
20180—016
20190—090
20200—034
20210—022
20220—09
20230—015
20240—027
20250—07
20260—0—
FIG. 1 — NSC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NSC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NSC devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K063151Humapen Luxura HDEli Lilly and Co. · 20071cites it

Which NSC devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K063151Humapen Luxura HDEli Lilly and Co. · 20072generations

What has FDA decided in NSC lately?

  • K063151Humapen Luxura HDEli Lilly and Co. · 2007

The one NSC decision →

Related product codes

Other codes under 21 CFR 880.5860.

QOG Injection Data Capture DeviceMZM Fibrin Sealant Preparation DeviceQLF On-Body InjectorFMF Syringe, PistonQLY Ophthalmic SyringeQBL Piston Syringe LeverNKN Syringe, Piston, ReprocessedPQX Epinephrine SyringeQEH Piston Syringe With Neuraxial Connector –…QNQ Low Dead Space Piston SyringePUR Vacuum SyringeMEG Syringe, Antistick